RECRUITING

A Direct-to-Consumer Study Investigating the Effect of Specific Cannabinoid Products on Motivation, Energy Level, Focus, and Appetite in Healthy Adults

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Tetrahydrocannabivarin (THCV) is a rare cannabinoid and is a homologue of THC that differs only in the length of the alkyl side chain (3C vs 5C, respectively). Pre-clinical and clinical trials have shown that THCV has medical potential as a neuroprotectant, anti-inflammatory, anti-anxiety, and most notably as a therapeutic to improve glycemic control in type 2 diabetic patients. Several THCV products are available in states with recreational cannabis. Anecdotal reports from adult cannabis users indicate that THCV provides an energizing, focusing and euphoric high-while still creating a lucid, uplifting experience. Additionally, unlike THC-dominant products, THCV was not reported to increase appetite. Other anecdotal comments referring to increased ability to focus for long periods of time and being more active were common. Given anecdotal evidence, which shows that THCV is activating and improving focus, this provides rationale and justification to conduct a clinical research study to further test and understand whether THCV improves motivation, focus, level of energy, and does not stimulate appetite in healthy adults.

Official Title

A Direct-to-Consumer, Randomized, Double-blind, Placebo-controlled, Double Cross-over Study Investigating the Effect of Specific Cannabinoid Products on Motivation, Energy Level, Focus, and Appetite in Healthy Adults

Quick Facts

Study Start:2023-08-14
Study Completion:2024-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06213064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Healthy adults age \> 21 years old
  2. 2. Work / study / play in an environment that requires focus
  3. 3. Able to read and understand English
  4. 4. Able to read, understand, and provide informed consent
  5. 5. Able to use a personal smartphone device and download Chloe by People Science
  6. 6. Able to complete study assessments over the course of up to 14 days
  7. 7. Familiar with the use of cannabis and its effects
  8. 8. Able to tolerate at least 5mg THC
  9. 9. Willingness to abstain from use of any THC containing products during study product use days
  10. 10. Willingness to abstain from use of alcohol during study product use days
  11. 11. Greater Los Angeles area residents only
  1. 1. Participants who do not have a smartphone and/or internet access
  2. 2. Any known adverse effects from taking cannabis
  3. 3. Concomitant Therapies: Currently taking medication for ADHD or psychotropic medications
  4. 4. Other Illnesses or Conditions: Participants who have the following co-morbidities are excluded:
  5. 1. History or currently undergoing product use for substance abuse disorders
  6. 2. Currently pregnant, planning to become pregnant within the next month, or breastfeeding
  7. 3. Allergies to formulation ingredients
  8. 4. Current or prior psychotic disorder
  9. 5. Immunosuppressive product uses, including organ transplant participants, active immunotherapy for cancer product use
  10. 6. Any condition that is considered by investigator to be a contraindication to cannabis (e.g. specific drug-use interaction, unstable cardiac arrhythmia)

Contacts and Locations

Study Contact

Amy Kazaryan, MPhil
CONTACT
8184528996
amy@peoplescience.health
Crisel Erfe, MD
CONTACT
310-922-0609
crisel@peoplescience.health

Principal Investigator

Noah Craft, MD
PRINCIPAL_INVESTIGATOR
People Science, Inc.

Study Locations (Sites)

People Science, Inc.
Los Angeles, California, 90034
United States

Collaborators and Investigators

Sponsor: Phylos Bioscience, Inc.

  • Noah Craft, MD, PRINCIPAL_INVESTIGATOR, People Science, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-14
Study Completion Date2024-06-01

Study Record Updates

Study Start Date2023-08-14
Study Completion Date2024-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Motivation